التفاصيل البيبلوغرافية
| العنوان: |
Health-Related Quality of Life and Treatment Satisfaction in Parents and Children with Type 1 Diabetes Using Closed-Loop Control. |
| المؤلفون: |
Cobry, Erin C1 (AUTHOR), Kanapka, Lauren G2 (AUTHOR), Cengiz, Eda3 (AUTHOR), Carria, Lori3 (AUTHOR), Ekhlaspour, Laya4 (AUTHOR), Buckingham, Bruce A4 (AUTHOR), Hood, Korey K4 (AUTHOR), Hsu, Liana J4 (AUTHOR), Messer, Laurel H1 (AUTHOR), Schoelwer, Melissa J5 (AUTHOR), Emory, Emma5 (AUTHOR), Ruedy, Katrina J2 (AUTHOR), Beck, Roy W1 (AUTHOR), Wadwa, Raj Paul1 (AUTHOR), Gonder-Frederick, Linda5 (AUTHOR), iDCL Trial Research Group (CORPORATE AUTHOR) |
| المصدر: |
Diabetes Technology & Therapeutics. Jun2021, Vol. 23 Issue 6, p401-409. 9p. |
| مصطلحات موضوعية: |
*QUALITY of life, *TYPE 1 diabetes, *PATIENT satisfaction, *CLINICAL trial registries, *PARENTS, *INSULIN pumps, *INSULIN therapy, *RESEARCH, *BLOOD sugar monitoring, *HYPOGLYCEMIC agents, *BLOOD sugar, *SATISFACTION, *EVALUATION research, *COMPARATIVE studies, *RANDOMIZED controlled trials, *RESEARCH funding, *STATISTICAL sampling |
| مستخلص: |
Introduction: Hybrid closed-loop systems increase time-in-range (TIR) and reduce glycemic variability. Person-reported outcomes (PROs) are essential to assess the utility of new devices and their impact on quality of life. This article focuses on the PROs for pediatric participants (ages 6-13 years) with type 1 diabetes (T1D) and their parents during a trial using the Tandem Control-IQ system, which was shown to increase TIR and improve other glycemic metrics. Research Design and Methods: One hundred and one children 6 to 13 years old with T1D were randomly assigned to closed-loop control (CLC) or sensor-augmented pump (SAP) in a 16-week randomized clinical trial with extension to 28 weeks during which the SAP group crossed over to CLC. Health-related quality of life and treatment satisfaction measures were obtained from children and their parents at baseline, 16 weeks, and 28 weeks. Results: Neither the children in the CLC group nor their parents had statistically significant changes in PRO outcomes compared with the SAP group at the end of the 16-week randomized controlled trial and the 28-week extension. Parents in the CLC group reported nonsignificant improvements in some PRO scores when compared with the SAP group at 16 weeks, which were sustained at 28 weeks. Sleep scores for parents improved from "poor sleep quality" to "adequate sleep quality" between baseline and 16 weeks, however, the change in scores was not statistically different between groups. Conclusions: Children with T1D who used the Control-IQ system did not experience increased burden compared with those using SAP based on person-reported outcomes from the children and their parents. Clinical Trials Registration: NCT03844789. [ABSTRACT FROM AUTHOR] |
| قاعدة البيانات: |
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